Statistical methods for seamless phase II/III design
Author:
Affiliation:
1. MSDKK, Graduate School of Comprehensive Human Sciences, University of Tsukuba
2. Department of Biostatistics, Faculty of Medicine, University of Tsukuba
Publisher
The Biometric Society of Japan
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjb/43/1/43_37/_pdf
Reference72 articles.
1. Armitage, P., McPherson, C.K., and Rowe, B.C. (1969). Repeated significance tests on accumulating data．Journal of the Royal Statistical Society. Series A (General) 132, 235-244.
2. Bauer, P., Bretz, F., Dragalin, V., König, F., and Wassmer, G. (2016). Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls．Statistics in Medicine 35, 325-347.
3. Bauer, P. and Kieser, M. (1999). Combining different phases in the development of medical treatments within a single trial．Statistics in Medicine 18, 1833-1848.
4. Bauer, P. and Köhne, K. (1994). Evaluation of experiments with adaptive interim analyses．Biometrics 50, 1029-1041.
5. Bischoff, W. and Miller, F. (2009). A seamless phase II/III design with sample-size re-estimation}．Journal of Biopharmaceutical Statistics 19, 595-609.
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